MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC STERNAL ZIPFIX WITH NEEDLE STERILE/20 PACK; CERCLAGE, FIXATION

Model Number	08.501.001.20S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation could not be completed; no conclusion could be drawn, as no product was received.(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 or Problem Description
It was reported that during a reapproximation of the sternum procedure with sternum plates and screws on (b)(6) 2020, three sternal zipfix were broken.It was believed that the size of the patient may have contributed to the issue.The surgeon stated that he should have used more fixation due to the patient size.The procedure was successfully completed.Patent is recovering.There was no surgical delay.Concomitant device reported: unknown sternum plate (part # unknown, lot # unknown, quantity unknown), unknown screws (part # unknown, lot # unknown, quantity unknown).This report is for one (1) sternal zipfix with needle sterile/ 20 pack.This is report 1 of 3 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Investigation flow: damage.Visual inspection: the two sternal zipfix needle sterile devices of the 20 pack (p/n: 08.501.001.20s, lot #: 5l45698) were returned and received at us cq.Upon visual inspection.It was observed that the distal tips of the devices were broken.No other issues were identified with the returned devices.Device failure/defect identified? yes.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Furthermore, the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the design of the device.Document/specification review: based on the date of manufacture drawings of the current and manufactured revision of drawings were reviewed.Complaint confirmed? yes, the devices received were broken.Hence confirming the allegation.Investigation conclusion: the complaint condition was confirmed for the two sternal zipfix needle sterile/20 pack (p/n: 08.501.001.20s, lot #: 5l45698).There is no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: provided part/lot combination is not correct, lot 5l45698 was used for part 08.501.001.20s and not 08.501.001.01s, therefore the dhr review was made for the package with (b)(4) pieces: part: 08.501.001.20s, lot: 5l45698, manufacturing site: bettlach, release to warehouse date: oct.29, 2019, expiry date: oct.31, 2024.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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.

• Brand Name: STERNAL ZIPFIX WITH NEEDLE STERILE/20 PACK
• Common Device Name: CERCLAGE, FIXATION
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9848102
• Report Number: 2939274-2020-01321
• Device Sequence Number: 740185
• Product Code: JDQ
• UDI-Device Identifier: 20887587025992
• UDI-Public: (01)20887587025992
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2024
• Device Model Number: 08.501.001.20S
• Device Catalogue Number: 08.501.001.20S
• Device Lot Number: 5L45698
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2020
• Initial Date Received by Manufacturer: 02/19/2020
• Supplement Date Received by Manufacturer: 04/09/2020
• Initial Report FDA Received Date: 03/18/2020
• Supplement Report FDA Received Date: 04/13/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - PLATES; UNK - SCREWS: TRAUMA; UNK - ZIPFIX IMPLANTS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 41 YR
• Patient Weight: 116