MAUDE Adverse Event Report: SYNTHES (USA); SCREW,FIXATION,BONE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 09/14/2016

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient id-case# (b)(6).Patient information is not available for reporting.Potential part numbers for the three stripped screws are: 02.214.111, 02.214.112, 02.214.113.For 02.214.111: 1.5mm cortex screw self-tapping with t4 stardrive recess 11mm, screw, fixation, bone, hwc, (b)(4) lot unknown, k112583 for 02.214.112: 1.5mm cortex screw self-tapping with t4 stardrive recess 12mm, screw, fixation, bone, hwc, (b)(4) lot unknown, k112583 for 02.214.113: 1.5mm cortex screw self-tapping with t4 stardrive recess 13mm, screw, fixation, bone, hwc, (b)(4) lot unknown, k112583 the screws were not implanted/explanted.The subject device is not expected to be returned to the synthes manufacturer for evaluation.(b)(4).Without a lot number the device history records review could not be completed.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 is reported surgeon was attempting to implant the 1.5mm variable angle (va) straight plate with 12 holes on the head of the right metacarpal.During the procedure, it was noted that the heads of three (3) of the screws had become stripped.After the first screw was stripped and suspecting the self-retaining screwdriver shaft may be the cause, surgeon swapped out the shaft for another in the set.With the other shaft, an additional two (2) screw heads became stripped.It is further reported the plate had also become damaged.Surgeon opted to remove the plate and ten (10) screws.Of the three (3) that were stripped, the most proximal screw had to be burred in order to remove it.Surgeon then used k-wires to cerclage the fracture.Surgery was delayed approximately one (1) hour but was completed successfully.This complaint is for three unknown screws that stripped.This is report number 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device returned for investigation november 4, 2016 a product development investigation was performed for the unknown cortex screws (part number unknown, lot number unknown).The subject device was returned with the complaint condition stating the screw head recesses are all severely damaged / burred consistent with stripping during insertion and removal.One (1) plate and four (4) screws were received at customer quality (cq) for investigation.Using calipers with reference to product drawing, it was determined that quantity three (3) of the returned screws are most likely part #02.214.112 and quantity one (1) is most likely 02.214.113.However, this can not be definitively determined without lot numbers to verify.The returned plate measures approximately 33mm in length and has been cut and bent.Only a section of seven (7) holes exists on the returned plate, therefore a section of five (5) holes (approximately 24mm in length) was not returned for evaluation as measured using calipers with reference to product drawing.Furthermore, damage exists in all 7 of the locking holes.A review of the device history records was unable to be performed for the plate and screws since the lot numbers for the returned plate and screws are unknown.Visual inspection and relevant drawings for the returned plate and screws were reviewed the design, materials and finishing processes were found to be appropriate for the intended use of this device quantity two (2) of stardrive screwdriver shaft t4/50mm (03.130.010 lot 9923516) were received at cq with worn distal tips.Both show post manufacturing wear consistent with field usage.This complaint for qty 2 of 03.130.010 is confirmed.Visual inspection under 10x magnification and measurements confirm that neither is broken.No non-conformance records were generated during production of the screwdrivers.Review of the device history records showed that there were no issues during the manufacturing of this product that would contribute to this complaint condition.Relevant drawings for the returned devices were reviewed.The design, materials and finishing processes were found to be appropriate for the intended use of this device.The complaint could not be replicated for the following reasons: already damaged plate holes, damaged screw head recesses, and only cortex screws and no locking screws were returned.The complaint was confirmed and no root cause was able to be determined.This complaint is for four (4) unknown screws that stripped instead of three (3) screws which was originally reported.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Update: it was reported four (4) screws were stripped instead of three (3) and damaged out of ten (10) screws.Of the four (4) that were stripped, the most proximal screw had to be burred in order to remove it.This complaint is for four (4) unknown screws that stripped.

• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5991205
• MDR Text Key: 56071917
• Report Number: 2520274-2016-14747
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR