MAUDE Adverse Event Report: SYNTHES HAGENDORF PRODISC-C VIVO UNCEM CONVEX SIZ M 15*12; IMPLANT, FIXATION DEVICE, SPIN

Catalog Number 04.670.927S

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Code Available (3191)

Event Date 10/16/2017

Event Type  Injury  

Manufacturer Narrative

Patient information is unknown.(b)(4).(b)(6).Device is not distributed in the united states, but is similar to device marketed in the usa.A device history record review was performed for the subject device lot number 9342031.Manufacturing location: (b)(4).Date of manufacture: 29.Jan.2015.Expiry date: 01.Jan.2020.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.(b)(4).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

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that a prodisc c vivo size m, 15 mm x 12 mm, h7mm was requested by surgeon and after being removed from it's outer box a small hole was observed in the sterile packaging.Sales rep observed the removal of the unusable item and there is no way that the damage was caused by the person that removed it.The surgeon then requested the next size down as there was only one of this size in the loan kit.This implant was intact on the second implant and was used for the case.Concomitant parts reported: 1x prodisc®-c vivo, uncemented (part 04.670.927s lot 9342031).This is report 1 of 1 for (b)(4).

Manufacturer Narrative

A manufacturing investigation action was conducted/performed.The report indicates that the: evaluation was performed by (b)(6) ag with following result: sample analysis: based on the given field sample, (b)(6) confirm the complaint reason.A small cut near the folding area (about lmm long through both side of the ali -pe peel pouche) is visible.This cut is within the closing seal of the peel pouch.Outside the closing seal, a small round hole is visible as well (no influence to the sterile barrier).The alu-pe peel pouche was not open.The cardboard box for analysis was open on one face side.The shrink wrap was still over the box, only on the open face side the shrink wrap was missing.There were no visible injuries (knife, scalpel) visible outside and inside the box.Process overview: the employes are trained on the clean room handling and packaging processes.For every production step, a first piece inspection is required.Batch record review: (b)(6) ag performed a batch record review to observe protocolled incidents, which can be linked to the complaint.No deviations were found.All production and inspection steps are correctly documented.Investigation at (b)(6): the packaging process in the clean room and in the final packaging was checked on site for possible causes of the deviation.The small cut must have been caused by a sharp object i instrument.The small cut can not be caused during the peel pouch packaging process in the clean room, because there are no sharp, pointed tools used for the packaging process.Also during the final packaging (package the product in cardboard box) the cut can not be caused.As in the clean room, there are no sharp tools used in the final packaging area.Conclusion of the investigation: based on the given field sample and the investigation done, (b)(6) ag stated, that the cause of the cut or puncture is not manufacturing related and (b)(6) reject this complaint.The damage at the pouche did not occurr during the manufacturing process, the damage was made post-manufacturing by a sharp instrument.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.

• Type of Device: IMPLANT, FIXATION DEVICE, SPIN
• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7013734
• MDR Text Key: 91495547
• Report Number: 3003875359-2017-10554
• Device Sequence Number: 1
• Product Code: JDN
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2020
• Device Catalogue Number: 04.670.927S
• Device Lot Number: 9342031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/17/2017
• Initial Date FDA Received: 11/09/2017
• Supplement Dates Manufacturer Received: 12/05/2017
• Supplement Dates FDA Received: 12/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ONE (1) QTY, PART 04.670.927S, LOT 9342031
• Patient Outcome(s): Required Intervention