MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH HOLDING SLEEVE FOR USS POLYAXIAL; MISC ORTHO SURGICAL INSTR

Catalog Number	03.607.003
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is j&j employee.The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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
Device report from synthes reports an event in (b)(6) as follows: it was reported that during loan kit inspection it was noticed that the one of the flexible jaws of holding sleeve for uss polyaxial has snapped off.No further information is reported.This report is for one (1) holding sleeve for uss polyaxial.This is report 1 of 1 for complaint (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.H3, h6: a product investigation was conducted.Complaint is confirmed as we are able to confirm complaint description (1 prong is broken off) based on the received pictures.Visual inspection: upon visual inspection of the complaint device it can be seen that one (1) of the four (4) prong is broken off, this thus confirming the complaint description.In addition, the instrument is in a very used condition with impression marks and scratches all over, which is an indication of regular use through its 12 years of lifespan.Document/specification review: drawings and revisions are in accordance to dhr of production lot 1730885.All relevant features are defined on the used drawing revisions of dhr of production lot 1730885.The reported devices were assembled according to drawing, and those went through a 100% functional test (checked according to inspection instruction), before they had left the production in august 2007.Summary: the cause of complained malfunction is a post-manufacturing caused and/or use related, therefore the in the investigation flow listed remaining investigation steps are not required.As per selected investigation flow, the investigations performed didn¿t identify any manufacturing defect or deficiency, thus the complaint investigation is considered as not manufacturing related.A root cause could not be determined, most likely rough handling or the use of excessive force during surgeries over the device 12 year lifespan could led to the complaint description.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.H3, h4, h6: a device history record (dhr) review was conducted: part: 03.607.003, lot: 1730885, manufacturing site: hägendorf, release to warehouse date: 22.Aug.2007.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: HOLDING SLEEVE FOR USS POLYAXIAL
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9512288
• Report Number: 8030965-2019-71382
• Device Sequence Number: 388323
• Product Code: LXH
• UDI-Device Identifier: 07611819185395
• UDI-Public: (01)07611819185395
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 03.607.003
• Device Lot Number: 1730885
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Initial Date Received by Manufacturer: 12/04/2019
• Supplement Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 02/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1