MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SPEEDSHIFT(TM) IMPLANT KIT 15 X 20 MM, OFFSET 10 MM; STAPLE,FIXATION,BONE

Model Number	SE-1520-10
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
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 on february 10, 2020 that the customer received a broken product.There is no further information available.This report is for one (1) speedshift(tm) implant kit 15 x 20 mm, offset 10 mm.This is report 1 of 1 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.H3, h4, h6: part number: se-1520-10, bme lot number: bse170856, manufacturing date or release to warehouse date: november 30, 2017, place of manufacture: biomedical enterprises, san antonio, tx, lot expiration date: november 8, 2022.Dhr review: no ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Visual inspection: the returned implant holder is broken as reported.The package was received in an opened condition.Otherwise no other damages are visible.Drawing/specification review: the manufacturing review of the manufacturing documents shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.Summary: the complaint condition is confirmed as the plastic implant holder is broken as reported.The condition of the complaint device is consistent with prior issues with the same occurrence.This is addressed with capa.Review identified that lot# bse170856 was manufactured on november 30, 2017 prior to implementation of the raw material composition change in capa thus the complaint lot may be more prone to this failure mode than lots manufactured after action taken january 31, 2018.Furthermore, an additional action is planned (capa design remediation) for reduction/elimination of the identified failure mode.The root cause was identified during the performed customer quality (cq) evaluation and therefore the in the investigation flows listed remaining investigation steps are not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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: SPEEDSHIFT(TM) IMPLANT KIT 15 X 20 MM, OFFSET 10 MM
• Common Device Name: STAPLE,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10542063
• Report Number: 8030965-2020-07099
• Device Sequence Number: 3123820
• Product Code: JDR
• UDI-Device Identifier: 00810633020449
• UDI-Public: (01)00810633020449
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K142292
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/08/2022
• Device Model Number: SE-1520-10
• Device Catalogue Number: SE-1520-10
• Device Lot Number: BSE170856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Initial Date Received by Manufacturer: 02/10/2020
• Supplement Date Received by Manufacturer: 09/25/2020
• Initial Report FDA Received Date: 09/16/2020
• Supplement Report FDA Received Date: 09/28/2020
• Patient Sequence Number: 1