The dhr was reviewed for sterile kit p71-108-0808-s and lot 260315217b.The implant records were reviewed for part p70-108-0008, lot bdk6tc, bdk65sl, bdlc9wm, bdlc9wn, bdlv7xr, and edm-24171.The implant was measured within spec and no manufacturing or sterilization deviations were noted.The dhr for the kit p71-110-1010-s lot 260317717b was also reviewed.The implant dhrs (b)(4) were reviewed as well.The second implant measured in spec and no manufacturing or sterilization deviations were noted.
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It was reported that the patient underwent a surgical procedure for a bi-lateral akin procedure.The original surgery took place on (b)(6) 2017.According to the reporter, the first staple was not inserted flush with the bone so a second staple was then inserted.One staple broke post operatively after being implanted 4 weeks.The revision surgery took place on (b)(6) 2017.Both staples were removed during the revision surgery.During evaluation and investigation, the broken staple x-rays were evaluated and it was confirmed that the staple was broken along the proximal, angled arm.The part was not returned for physical analysis.The dhr for the sterile kits were reviewed as well as the manufacturing records for the implants used in the surgery.Both implants were manufactured according to specification with no deviations found.
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