MAUDE Adverse Event Report: SYNTHES HAGENDORF DEPTH GAUGE; GAUGE, DEPTH

Catalog Number 03.161.028

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: device broke intra-operatively and was not implanted / explanted.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.Device history records was conducted.The report indicates that the: part 03.161.028 lot 1678981, manufacturing location: (b)(4), manufacturing date: 11.Jul.2007.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No ncrs were generated during production.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that multiple damaged and worn instruments were discovered in a territory storage unit.There is no information available regarding involvement in any specific procedure.The jaws of one (1) rod cutter do not meet; they appear pitted and jagged.One (1) osteotome is pitted on the edge, not sharp.One(1) t-pal spacer applicator inner shaft is bent.Two (2) t25 stardrive shafts were discovered with a stripped tip.One (1) matrix internal driver was discovered with a stripped tip.One (1) depth gauge was discovered broken into three (3) pieces.One (1) bolt cutter head for 5.0mm fixation pins was discovered to be worn.One (1) bolt cutter handle 13mm width across flats was discovered to be worn.One (1) rod pusher was discovered to be worn.One (1) 40 degree up-biting laminectomy punch was discovered to be worn.One (1) countertorque wrench for cervical spine locking plate (cslp) was discovered to be worn.Three (3) holding sleeves-standard for matrix were discovered to be worn.One (1) holding sleeve for snap-on transconnectors was discovered to be worn.The tip is worn on one (1) distractor tip for matrix detachable holding sleeve.One (1) head removal tool for matrix was discovered to be worn.Two (2) torque limiting ratchet handles were discovered to be worn.One (1) transforaminal posterior atraumatic lumbar (t-pal) trial spacer was discovered to be worn.One (1) transforaminal posterior atraumatic lumbar (t-pal) spacer applicator knob was discovered to be worn.One (1) curved pedicle probe was discovered to be worn.Finally, one (1) locking holding sleeve-standard for matrix was discovered to be worn.This complaint involves 1 devices.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Implant and explant dates: device is an instrument and is not implanted/explanted.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported additionally, one (1) rod cutter has an unspecified functional issue and one (1) bolt cutter handle has an unspecified functional issue.All the complained parts were reviewed and assessed and it was determined only the broken depth gauge met reportability requirements.

Manufacturer Narrative

Product investigation summary: the following devices were examined with no defects or deficiencies identified that would inhibit intended device functionality.As such, the complaints related to the devices are unconfirmed: part 03.616.043, part 391.77, part 03.632.083, part 03.812.004, part 03.614.038, and part 03.616.042.For part 03.161.028: the returned device was examined and the complaint condition as able to be confirmed as the needle was found to be missing from the returned depth gauge body.Evidence of laser welding utilized to retain the subcomponent was noted; as such, the complaint condition is likely the result of rough handling and/or off-axis loading on the instrument.The relevant drawings for the returned instrument were reviewed.The design, materials, and finishing processes were found to be appropriate for the intended use of this device.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.No definitive root causes were able to be determined.The broken/damaged/worn devices were discovered in their current state; no knowledge of the events which led to the complaint conditions was known.Health professional selected in error on the initial medwatch.The only report source for this complaint was the company representative.Device used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was originally reported that multiple damaged and worn instruments were discovered in a territory storage unit.There was no information available that referenced any specific patient or procedural involvement.The reported malfunctions are listed below: the jaws of one (1) rod cutter did not meet and appeared to be pitted and jagged.The edge of one (1) osteotome appeared pitted, not sharp.One (1) transforaminal posterior atraumatic lumbar (t-pal) spacer applicator inner shaft was bent.The tips of two (2) t25 stardrive shafts were stripped.The tip of one (1) matrix internal driver was stripped.One (1) depth gauge was discovered in three (3) separate broken pieces.Seventeen (17) items were found in worn conditions: one (1) bolt cutter head for 5.0mm fixation pins; one (1) bolt cutter handle 13mm width across flats; one (1) rod pusher; one (1) 40 degree up-biting laminectomy punch; one (1) countertorque wrench for cervical spine locking plate (cslp); three (3) holding sleeves-standard for matrix; one (1) holding sleeve for snap-on transconnectors; one (1) distractor tip for matrix detachable holding sleeve; one (1) head removal tool for matrix; two (2) torque limiting ratchet handles; one (1) t-pal trial spacer; one (1) t-pal spacer applicator knob; one (1) curved pedicle probe; and one (1) locking holding sleeve-standard for matrix.An update received on july 12, 2016 added that one (1) rod cutter and one (1) bolt cutter handle had unspecified functional issues.Upon receipt of the devices, visual inspections confirmed the following information: the t-pal applicator inner shaft and the t-pal trial spacer were both broken and missing segments from their proximal ends.The 05l etching on the bolt cutter (for fixation pins) is not a lot number; rather, the marking is to indicate that the device is intended to be used with 5mm diameter pins.The handles on both bolt cutter handles were returned broken along with all of the generated fragments.The countertorque for cslp tip was found to be broken and missing a fragment from one of the four distal prongs.All three (3) of the matrix holding sleeves have broken tips with fragments that were not returned.The holding sleeve for snap-on transconnectors was received with a spring (approximately 8.5mm diameter and 1.5mm tall) missing.All devices have been assessed for reportability.At this time, only ten (10) of the documented issues were found to represent reportable incidents.This report is 3 of 10 for (b)(4).

• Brand Name: DEPTH GAUGE
• Type of Device: GAUGE, DEPTH
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5776663
• MDR Text Key: 49022739
• Report Number: 3003875359-2016-10402
• Device Sequence Number: 1
• Product Code: HTJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 06/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.161.028
• Device Lot Number: 1678981
• Other Device ID Number: (01)10705034711621(10)1678981
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/22/2016
• Initial Date FDA Received: 07/07/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/27/2016; 08/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1